Clinical trial · Interventional
Interleukin-2 With Sorafenib (BAY 43-9006) for Unresectable or Metastatic Clear Cell Renal Carcinoma (RCC) and Metastatic Melanoma
A Phase I Study of Bolus High Dose Interleukin-2 With Sorafenib (BAY 43-9006) in Patients With Unresectable or Metastatic Clear Cell Renal Carcinoma (RCC) and Metastatic Melanoma
NCT00418496CI-TRIAL-00026041completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The primary objective of this study will be to determine the toxicity and Maximum Tolerated Dose (MTD) of the combination of high dose aldesleukin and sorafenib in previously untreated patients with metastatic or unresectable clear cell renal carcinoma (RCC) and metastatic melanoma.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Melanoma | Melanoma | ONTOLOGY_EXACT | 0.98 |
| Renal Cancer | Kidney Neoplasm | PROBABILISTIC | 0.70 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Aldesleukin | Drug | Aldesleukin | ALIAS |
| Sorafenib | Drug | Sorafenib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Aldekleukin Plus Dose Escalation Sorafenib
- description
- Patients will be admitted to a dedicated nursing unit for HD aldesleukin administration. Patients will receive bolus aldesleukin at a dose of 600,000 IU/Kg every eight hours on days 1-5 with a goal of 10-12 doses.
- interventionNames
- Drug: Aldesleukin
- Drug: Sorafenib
Primary outcomes (1)
- measure
- Maximum Tolerated Dose (MTD)
- timeFrame
- up to 1 year
- description
- Determine the MTD for high dose (HD) aldesleukin and sorafenib in patients with metastatic or unresectable clear cell renal cell carcinoma and metastatic melanoma
Secondary outcomes (2)
- measure
- Determine the progression free survival.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients must have histologically or cytologically confirmed evidence of metastatic/ unresectable clear cell renal carcinoma. * Patients must have metastatic melanoma with no brain metastases. * Patients must have measurable disease. * No prior systemic treatment (One prior systemic treatment is allowed for metastatic melanoma patients. Excluded prior therapies include prior high dose aldesleukin, sorafenib and DTIC/TMZ.) * Age ≥ 18 years or older Exclusion Criteria: * Patients who are undergoing or have undergone surgery S weeks. * Patients who are pregnant (because of possible side effects on the fetus) Effective contraception will be discussed with each patient. * Patients with uveal melanoma.
References
Publications (1)
- RESULTMonk P, Lam E, Mortazavi A, Kendra K, Lesinski GB, Mace TA, Geyer S, Carson WE 3rd, Tahiri S, Bhinder A, Clinton SK, Olencki T. A phase I study of high-dose interleukin-2 with sorafenib in patients with metastatic renal cell carcinoma and melanoma. J Immunother. 2014 Apr;37(3):180-6. doi: 10.1097/CJI.0000000000000023. PMID 24598448